System, medical item including RFID chip, server and method for capturing medical data

ABSTRACT

A system includes a plurality of RFID chips affixed to a medical item, a data collection engine device, and a server device. The data collection engine wirelessly transmits power to a first one of the RFID chips and receives first medical data from the first RFID chip while the first RFID chip is activated by the power receiver. The data collection engine generates a first message indicative of the first medical data to be sent to the server device. The server device can determine aspects of the medical item based upon the first medical data.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 15/592,116 filed on May 10, 2017, which is acontinuation of U.S. patent application Ser. No. 15/390,695 filed onDec. 26, 2016 (now U.S. Pat. No. 9,679,108), which is a continuation ofU.S. patent application Ser. No. 15/004,535 filed on Jan. 22, 2016 (nowU.S. Pat. No. 9,569,589), which claims the benefit of U.S. ProvisionalPatent Application No. 62/113,356 filed on Feb. 6, 2015, the contentsall of which are incorporated herein by reference.

The present application incorporates by reference the contents of: U.S.Pat. No. 9,523,534 to Akbar Paydar et al.; U.S. Pat. No. 9,224,124 toMuhammad R. Rahim et al.; U.S. Pat. No. 8,414,417 to Suneil Mandava etal.; U.S. Patent Publication No. 20160092640 to Jimmy C. Caputo et al.;U.S. Patent Publication No. 2011/0202170 to Dennis K. Dawes et al.; U.S.Pat. No. 7,518,502 to Gene Edward Austin et al.; and U.S. Pat. No.5,535,141 to Andre Lussi.

TECHNICAL FIELD

The technical filed generally relates to a system including one or moremedical devices and items including radio-frequency identificationchips, and a server.

BACKGROUND

Medical facilities utilize or consume medical devices and otherconsumable items in the course of providing patient care. Examples itemsinclude catheters, medication, surgical implants, sterile wrappings,sterile gowns, sterile gloves, surgical operation sponges, stethoscopes,endoscopes, endotracheal tubes, etc. Some medical items are used onlyone time during a procedure, while others may be used repeatedly afterproper sterilization procedures, etc. The medical items may be stored orbe present within medical devices such as storage cabinets,refrigerators, trays, autoclave machines, etc. All of these types ofmedical items or devices will be referred to herein sometimes as medicalitems for the sake of brevity. Medical facilities usually haveprocedures for these types of medical items.

SUMMARY

A Radio-frequency Identification (RFID) chip can transmit information toa reader in response to an interrogation signal or polling request fromthe reader. Exemplary readers include the reader described in U.S. Pat.No. 7,518,502. The RFID chip can be incorporated in a tag (RFID tag)which is placed on a medical consumable item so that information can bepassively captured. An RFID tag can be an active-type with its own powersource, or a passive-type or battery-assisted passive type with no orlimited power source. Both the passive-type and battery-assisted passivetype will be referred to here as passive-type for sake of brevity.Placing an active-type RFID tag on some medical items may not befeasible because of financial considerations, weight, etc. On the otherhand, placing a passive-type RFID tag on medical items may be morefeasible; however, a power source will be needed to passively obtaininformation. Therefore, a device that can provide power to the RFID aswell as obtain the information from the RFID tag would be beneficial foractivity based costing and to ensure proper charging.

During medical procedures such as surgery, it is very important to avoiderrors such as using instruments that have not been properly sterilized,retaining the medical item in the patient after conclusion, performingsurgery on the wrong section of the body, performing the wrong surgicalprocedure or even performing surgery on the wrong patient. Some of theseerrors are commonly referred to as “surgical never events”. In order toavoid surgical never events, the position of a medical item, a patientwith respect to the medical item, as well as the medical items consumedare desirable information.

Prior to surgery, it is also very important to confirm that thenecessary instruments (medical items) are in the operating room. Amedical facility may have a system in which surgical preference cardsdefine the resources and preferences for specific procedures, includingsurgical materials, equipment, instructions, and setup. Not having thenecessary equipment, instruments, etc. can be a source of delay orinability to handle emergencies that may arise.

Medical items such as code carts include emergency medication/equipmentfor life support protocols. If a code cart does not have the necessaryequipment/medication when a code is called (i.e., a cardiac arrest forexample), an unnecessary death may occur.

Some medical instruments (items) are sterilized between uses by, forexample, an autoclave machine (another type of medical item). It isimportant to monitor when medical instruments were properly sterilized.

Some medical items such as medicines, blood/tissue must be stored intemperature controlled storage environments such as refrigerators. It isimportant to monitor the temperature of such refrigerators to make sureit is in accordance with the desired parameters for the medicalproducts. Further, access controls to prevent or hinder unauthorizedindividuals from accessing the refrigerator and/or medical products arealso beneficial.

In view of the above problems, as well as other concerns, the presentdisclosure concerns a system for capturing medical data from a medicalitem which includes an RFID chip.

According to various embodiments, the system includes a data collectionengine (DCE), a plurality of RFID chips associated with a plurality ofmedical items and or locations, and a server device.

The DCE includes a power transmission subsystem, a transceiver, acontroller operatively coupled to the transceiver, and a memoryincluding instructions for configuring the controller. The powertransmission subsystem includes a power source and an antenna arrangedto wirelessly transmit power to a passive-type RFID chip. Thetransceiver can communicate with a server device via a connection to anetwork such as a LAN, the Internet, or cellular network and alsowirelessly communicate with RFID chips. The controller is configured togenerate messages to be sent by the transceiver to the server device.The DCE can also communicate with a client device such as a smartphone.Rather than a DCE, or in conjunction with the DCE, the system caninclude a mobile device reader for sending an interrogation signal tothe RFID chips and receiving a message in reply to the interrogationsignal including a date and time stamp denoting the moment at which theinterrogation transaction occurred. The DCE can be a fixed unit fixed tothe ceiling of a room or a mobile reader for providing the power to theRFID tags by the interrogation signal.

The RFID chips can be incorporated in tags (RFID tags) which are placedon the medical items so that information can be passively captured. TheRFID tags can be associated with following exemplary medical items: anidentification badge; a patient wrist band; a trash receptacle, spineinstrumentation that measures information about the stress/force/momentat native human/implant interfaces; endoscopes; medical catheters;sponges to assist with sponge count at end of an operation and to ensurethat no sponge is left in the patient; hospital beds; surgical draintip; refrigerated storage units; endoscope cabinets; instrument trays;storage cabinets; autoclave machines, physical locations within hospitalfacilities, etc.

The RFID tag includes an antenna for communicating with the DCE ormobile device reader, other RFID tags and/or a client device such as asmartphone. If the RFID tag is passive-type, the antenna wirelesslyreceives power from, for example, the DCE, another RFID tag or theclient device. The RFID tag further includes a controller configured bya memory, a microcontroller or dedicated logic for generating messagesto be transmitted and a sensor group.

The server device includes a transceiver, a controller coupled to thetransceiver, and memory portions including instructions for configuringthe controller and providing one or more databases related to themedical consumable items. The transceiver can communicate with the DCEvia a connection to the network.

The system can be deployed for a single tenant (enterprise or privatecloud deployment) and/or shared across multiple facilities (multi-tenantcloud deployment).

In the system according to a first embodiment, RFID tags send medicaldata to a DCE, the date and time of this transaction is captured, theDCE transmits messages indicative of the medical data to the serverdevice, which stores the medical data in one or more databases. A clientdevice can request data retrieval of certain medical data from theserver. Moreover, a plurality of events can be determined on the RFIDchip level.

According to an aspect, a first RFID chip, which is a passive-type RFIDchip, is activated by power received from the power transmissionsubsystem of the DCE or of another RFID chip. While activated by thereceived power, the first RFID chip transmits first medical dataindicative of a first event which is received by the transceiver of theDCE. The date and time of the RFID and DCE communication is alsocaptured. The controller of the DCE is configured to generate a firstmessage indicative of the first medical data to be sent by thetransceiver to the server device via a network connection immediately orat a later time, for example if a network connection is not currentlyavailable. A date and time stamp denoting the date and time of thecommunication between the server and the DCE is captured and stored bythe server, in addition to the date and time stamp of the messagetransaction(s) between RFID chips and the DCE.

According to an aspect, the transceiver of the DCE can receiveidentification data from the first RFID chip while the first RFID chipis activated by the received power. The controller of the DCE can beconfigured to store the identification data in the memory to beassociated with the first RFID chip and to generate the first message toinclude the identification data.

According to an aspect, the transceiver of the DCE is further configuredto receive second medical data from a second RFID chip which is anactive-type RFID chip having its own power source. The controller of theDCE is further configured to generate a second message indicative of thesecond medical data to be sent by the transceiver to the server devicevia the network connection immediately or at a later time, for exampleif a network connection is not currently available. A date and timestamp denoting the date and time of the communication between the serverand the DCE is captured and stored by the server, in addition to thedate and time stamp of the message transaction(s) between RFID chips andthe DCE.

According to an aspect, the second RFID chip can receive third medicaldata from a third RFID chip when the third RFID chip is more or lessthan a predetermined distance from the second RFID chip including thedate and time stamp of the communication transaction between the secondRFID chip and the third RFID chip. The second medical data received bythe transceiver of the DCE according to the third aspect can furtherinclude the third medical data associated with both the second and thirdRFID chips and respective date and time stamps for each includedcommunication transaction.

According to an aspect, the power transmission subsystem is furtherarranged to transmit power to a second passive-type RFID chip foractivating the second RFID chip. The transceiver of the DCE of the firstaspect receives second medical data from the second passive-type RFIDchip indicative of a second event when a third RFID chip is more or lessthan a predetermined distance from the second passive-type RFID chipwhile the second passive-type RFID chip is activated by the power. Thecontroller of the DCE is configured to generate a message indicative ofthe second medical data to be sent by the transceiver to the server viathe network connection, immediately or at a later time, includingrespective date and time stamps for each communication transactionmaking up the data.

According to an aspect, the first RFID tag of the first aspect isassociated with an identification for a medical professional or apatient, and the first medical data includes identification informationof the first RFID tag, location data and a time duration in which theidentification has been in a particular location.

According to an aspect, the transceiver is further configured to receivea data storage request from a client device, the data storage requestincluding data associated with a second RFID tag coupled to the clientdevice, and the controller is further configured to generate anothermessage including the data storage request to be sent to the serverdevice.

According to an aspect, the transceiver of the server device isconfigured to receive the message from the DCE, wherein the message fromthe DCE includes at least an identification associated with the firstRFID tag and a date and time stamp of the communication transactionbetween the DCE and RFID chip; the server stores this data along withthe date and time stamp of the communication between the server and DCE.The transceiver is further configured to receive an information requestfrom a client device and to send an information reply including usageparameters associated with the first RFID tag to the client device. Theserver device includes one or more memory sources operatively coupled tothe controller. The memory sources include a database and instructionsfor configuring the controller. The instructions configure thecontroller to: determine data in the database that is associated withthe identification for the first RFID tag in the information request;generate the information reply including the usage parameters associatedwith the first RFID tag based upon the determined data; and store datain the message from the DCE in the database to be associated with theidentification of the first RFID tag.

According to an aspect, the server device includes a transceiverconfigured to receive a plurality of messages from the DCE, a controlleroperatively coupled to the transceiver; and one or more memory sourcesoperatively coupled to the controller, the one or more memory sourcesincluding instructions for configuring the controller to determine basedupon medical events included in the plurality of messages whether amedical item associated with the first RFID tag has been consumed,whether the medical item is being stored in conditions that do not meetspecified criteria, for example out of the required temperature range orat a time equal to or exceeding the expiration date, whether the medicalitem is in a cleaning a sterilization state that does not meet requiredcriteria, among other determinations.

In the system according to a second embodiment, RFID tags send medicaldata to a DCE, which transmits messages indicative of the medical datato the server device in an immediate or delayed fashion, and the serverdevice stores the medical data in a database. The server device and/orthe DCE and/or another entity can determine whether events such as anever event, a consumption event, and/or a charging event, storage notmeeting criteria event, use in an out of compliance cleaning orsterilization state, or other event (all referred to here as the event)has occurred based upon the medical data received from the RFID tags,location data, medical item data, patient data and medical professionaldata stored in the database. A client device can request data retrievalof certain medical data.

The server and/or the DCE can be configured to determine whether theevent has occurred based upon at least the parameters in the medicaldata obtained from the RFID tags such as proximity to another RFID tag,duration of the proximity and orientation values, temperature values,sterilization history, etc.

According to an aspect of the second embodiment, a server devicereceives messages from a plurality of first RFID tags affixed to amedical item and a second RFID tag associated with an individual such asa patient, medical professional or other medical item. The first RFIDtag can be a passive-type RFID tag activated by power received from theDCE or an active-type RFID tag. The second RFID tag can be a tag on apatient wristband, an identification badge, or a medical item. Theserver device includes a transceiver configured to receive the messages.The messages from the plurality of first RFID tags affixed to themedical item include input attributes of the medical item. The messagefrom the second RFID tag associated with the patient can include apatient, medical professional, or medical item identification. Theserver device includes a controller operatively coupled to thetransceiver and one or more memory sources operatively coupled to thecontroller.

The one or more memory sources storing a first database including aplurality of identifications associated with a plurality of patients,medical professionals, medical items, and attributes for each of theplurality of identifications.

The one or more memory sources further include instructions forconfiguring the controller to determine: a present orientation of thepatient, medical professional, or medical item based upon the inputattributes and to determine if the present orientation corresponds withone or more of the attributes associated with the patient, medicalprofessional, or medical item in the patient database; a present state(such as temperature) of a device in which medical items are present andto determine if the present state is, for example, a dangeroustemperature or in violation of compliance requirements such as acleaning and sterilization cycle.

According to an aspect of the server device, the attributes includes asurgical procedure scheduled for a patient; and the controller isfurther configured to determine a present patient orientation of thepatient corresponds with the surgical procedure scheduled. Theattributes may also include appropriate storage temperature range for amedical item and the controller is configured to determine if thecurrent storage temperature is in compliance. In addition, theattributes include expiration date for a medical item and the controlleris configured to determine whether the medical item is expired.Furthermore the attributes might include historical knowledge of thecleaning and sterilization cycle for a medical item and the controlleris configured to determine whether current use is out of compliance withcleaning and sterilization cycle requirements. The above are exemplary,but not all inclusive of the determinations the server's controller isconfigured to make.

According to an aspect of the server device, the one or more memorysources store a second (medical professional) database including medicalprofessional identifications associated with medical professionals, andattributes related to each of the medical professional identifications,and the plurality of messages further include an indication that a thirdRFID tag associated with one of the medical professionals is less than apredetermined distance from the second RFID tag associated with the onepatient.

According to an aspect of the server device, the one or more memorysources store a medical item database including medical itemidentifications associated with different medical items, and attributesrelated to each of the medical item identifications, and the pluralityof messages further include an indication that a third RFID tagassociated with one of the medical items is less than a predetermineddistance from the second RFID tag associated with the one medical item.

According to an aspect, the server device receives the one or moremessages from a DCE via a connection to a network, the DCE includes: apower transmission subsystem including a power source and an antennaarranged to wirelessly transmit power from the power source to one ormore of the plurality of first RFID tags; a transceiver configured toreceive first medical data from one or more of the plurality of firstRFID tags and the patient or medical item identification of the secondRFID tag associated with the patient or medical item, the medical dataincluding the input attributes of the plurality of first RFID tags; acontroller operatively coupled to the transceiver; and one or morememory sources operatively coupled to the controller, the one or morememory sources including instructions for configuring the controller togenerate a first message indicative of the first medical data to be sentby the transceiver to the server via a network connection.

According to an aspect, the server device is configured to use a trainedmodel such as a Neural Network Model (NNM) to predict an event basedupon the input attributes received from the RFID tags to, for example,determine if the patient is in a correct position based.

It should be noted that all or some of the aspects of the first andsecond embodiments can be combined.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, in which like reference numerals refer toidentical or functionally similar elements, together with the detaileddescription below are incorporated in and form part of the specificationand serve to further illustrate various exemplary embodiments andexplain various principles and advantages in accordance with the presentinvention.

FIG. 1 illustrates an exemplary operating environment in which a DataCollection Engine (DCE) receives medical data from RFID chips associatedwith medical items and transmits the medical data to a server via aconnection to a network according to exemplary embodiments.

FIG. 2 is a block diagram illustrating exemplary portions of the DCEaccording to exemplary embodiments.

FIG. 3A is a block diagram illustrating exemplary portions of apassive-type RFID chip associated with a medical item according toexemplary embodiments.

FIG. 3B is a block diagram illustrating exemplary portions of anactive-type RFID chip associated with a medical item according toexemplary embodiments.

FIG. 4A-4B illustrate an exemplary operating environment in which one ormore DCEs receive medical data from RFID chips associated with medicalitems, medical professionals and a patient according to a firstembodiment.

FIG. 5 illustrates an exemplary operating environment in which asmartphone receives medical data from RFID chips associated with medicalitems, medical professionals and a patient according to a modificationto the first embodiment.

FIG. 6-8 are flow diagrams illustrating exemplary operations of the DCEand RFID chips associated with medical consumable items, medicalprofessionals and a patient according to the first embodiment.

FIGS. 9A-9G illustrate an exemplary operating environment in which oneor more DCEs receive medical data from RFID chips associated withmedical items, medical professionals and a patient according to thefirst embodiment.

FIG. 10 is a flow diagram illustrating exemplary operations of the RFIDchips in medical items and the DCE according to the exemplary operatingenvironment shown in FIGS. 9A-9G.

FIG. 11 is a block diagram illustrating exemplary portions of a serverdevice according to various exemplary embodiments.

FIG. 12A is a perspective view of an operating table including aplurality of RFID chips according to an exemplary second embodiment.

FIG. 12B is a diagram illustrating a top view of the operating table ofFIG. 12A.

FIG. 13A is a perspective view of a donut headrest including a pluralityof RFID chips according to the second embodiment.

FIG. 13B is a schematic view of a patient's head positioned within thedonut headrest of FIG. 13A.

FIG. 13C is a diagram illustrating a top view of the operating tableincluding the donut headrest according to the second embodiment.

FIG. 14A is a perspective view of a patient positioned on her leftshoulder on the operating table.

FIG. 14B is a block diagram illustrating the position signaturesdetected and communicated by the RFID chips on the donut headrest andthe operating table according to the second embodiment.

FIG. 15A is a diagram illustrating a skull clamp headrest including aplurality of RFID chips according to the second embodiment.

FIG. 15B is a diagram illustrating the skull clamp portion of theMayfield headrest according to the second embodiment.

FIGS. 15C-15F are diagrams illustrating various orientations of apatient's head positioned in the skull clamp and the detected positionsignatures.

FIG. 16A is a diagram illustrating an endotracheal tube including aplurality of RFID chips according to the second embodiment.

FIG. 16B is a view of the endotracheal tube positioning within apatient.

FIG. 17 is a diagram illustrating a patient on an operating tableincluding the skull clamp headrest of FIG. 15A and the endotracheal tubeof FIG. 16A.

FIG. 18 is a diagram illustrating an adhesive eyelid occlusive dressingincluding an RFID chip according to the second embodiment.

FIG. 19 is a perspective view of a horse-shoe headrest including aplurality of RFID chips according to the second embodiment.

FIG. 20A is a diagram illustrating a sterilization case including anRFID chip.

FIG. 20B is a diagram illustrating a sealed wrap over the sterilizationcase.

FIG. 21 is a perspective view illustrating a medical instrument with anRFID tag located on an outer surface of the instrument.

FIG. 22 is a perspective diagram of a medicine storage cabinet includingan RFID tag on an outer surface.

FIG. 23 is diagram illustrating exemplary medicines stored in themedicine storage cabinet.

FIG. 24 is a diagram illustrating an opened drawer in the medicinestorage cabinet.

FIG. 25 is a perspective diagram illustrating an exemplary endoscopestorage cabinet.

FIG. 26 is a perspective diagram illustrating an exemplary autoclavemachine.

FIG. 27 is a diagram illustrating an exemplary climate controlled tissuestorage cabinet.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

In overview, the present disclosure concerns a Data Collection Engine(DCE), RFID chips for medical items and for identification tags ofmedical professionals and patients, and a server device.

The instant disclosure is provided to further explain in an enablingfashion the best modes of performing one or more embodiments of thepresent invention. The disclosure is further offered to enhance anunderstanding and appreciation for the inventive principles andadvantages thereof, rather than to limit in any manner the invention.The invention is defined solely by the appended claims including anyamendments made during the pendency of this application and allequivalents of those claims as issued.

It is further understood that the use of relational terms such as firstand second, and the like, if any, are used solely to distinguish onefrom another entity, item, or action without necessarily requiring orimplying any actual such relationship or order between such entities,items or actions. It is noted that some embodiments may include aplurality of processes or steps, which can be performed in any order,unless expressly and necessarily limited to a particular order; i.e.,processes or steps that are not so limited may be performed in anyorder.

Reference will now be made in detail to the accompanying drawings.Wherever possible, the same reference numbers will be used throughoutthe drawings to refer to the same or like parts.

Referring to FIG. 1, an exemplary operating environment in which thesystem according to various embodiments can be implemented will bediscussed. The environment includes a DCE 102 communicating with a firstRFID chip 108 disposed in a first room 104 and a second RFID chip 110disposed in a second room 106. Each of the RFID chips 108, 110 isassociated with a medical item. As discussed more fully below, thecommunication between the RFID chips 108, 110 and the DCE 102 ispreferably wireless; however, wireline communication or a combination ofwireless and wireline communication can also be used in some cases. TheDCE 102, although shown here as a single entity, can includesub-portions in each of the rooms 104, 106. The DCE 102 communicateswith one or more server devices represented generally by server 114 viaa connection to a network 112 such as a local area network (LAN), widearea network (WAN), the Internet, etc. The first and second rooms 104,106 can be, for example, separate rooms of a hospital facility. Thecommunication between the DCE 102 and the RFID chips 108, 110 and/orbetween the DCE 102 and the server 114 can be encrypted or unencrypted.The network 112 can be, for example, a private LAN for the hospitalfacility. The server 114 can be a computing device local to the hospitalfacility. On the other hand, the network 112 can be the Internet, theDCE 102 can be local to the hospital facility and the server 114 can beone or more remote computing devices. The DCE 102 can be a reader devicesuch as, for example, the TSL 1128 Handheld RAIN RFID reader made byIMPINJ™. One of ordinary skill in the art should appreciate that theserver 114 can represent entities necessary for providing cloudcomputing such as infrastructure and service providers.

Referring to the block diagram of FIG. 2, portions of an exemplary DCE200 will be discussed. The DCE 200 includes a transceiver 202, a powersource 203, an interface 206, a controller 208 and one or more memoryportions depicted by memory 210.

Referencing the Open Systems Interconnection reference model (OSImodel), the transceiver 202 can provide the physical layer functionssuch as modulating packet bits into electromagnetic waves to betransmitted and demodulating received waves into packet bits to beprocessed by higher layers (at interface 206). The transceiver 202 caninclude an antenna portion 205, and radio technology circuitry such as,for example, ZigBee, Bluetooth and WiFi, as well as an Ethernet and aUSB connection. The transceiver 202 also includes a wireless powertransmitter 204 for generating a magnetic field or non-radiative fieldfor providing energy transfer from the power source 203 and transmittingthe energy to, for example, an RFID chip by antenna portion 205. Thepower transmitter 202 can include, for example, a power transmissioncoil. The antenna portion 205 can be, for example, a loop antenna whichincludes a ferrite core, capacitively loaded wire loops, multi-turncoils, etc. In addition to energy transfer, the transceiver portion 202can also exchange data with the RFID chip. Data transmission can be doneat, for example, 1.56 MHz. The data can be encoded according to, forexample, Amplitude Shift Keying (ASK). The transceiver 202 includes apower transmission system composed of the antenna 205 and the powertransmitter 204.

The interface 206 can provide the data link layer and network layerfunctions such as formatting packet bits to an appropriate format fortransmission or received packet bits into an appropriate format forprocessing by the controller 208. For example, the interface 206 can beconfigured to encode or decode according to ASK. Further, the interface206 can be configured in accordance with the 802.11 media access control(MAC) protocol and the TCP/IP protocol for data exchange with the servervia a connection to the network. According to the MAC protocol, packetbits are encapsulated into frames for transmission and the encapsulationis removed from received frames. According to the TCP/IP protocol, errorcontrol is introduced and addressing is employed to ensure end-to-enddelivery. Although shown separately here for simplicity, it should benoted that the interface 206 and the transceiver 202 may be implementedby a network interface consisting of a few integrated circuits.

The memory 210 can be a combination of a variety of types of memory suchas random access memory (RAM), read only memory (ROM), flash memory,dynamic RAM (DRAM) or the like. The memory 210 includes instructions forconfiguring the controller 208 to execute processes such as generatingmessages representative and indicative of medical data and eventsreceived from RFID chips and/or determining the occurrence of one ormore events as discussed more fully below.

The controller 208 can be a general purpose central processing unit(CPU) or an application specific integrated circuit (ASIC). For example,the controller 208 can be implemented by a 32 bit microcontroller. Thecontroller 208 and the memory 210 can be part of a core (not shown).

Referring to FIG. 3A, portions of an exemplary passive-type RFID chip304 will be discussed. The RFID chip 304 can include an antenna portion306, a power receiver 308, an interface 310 and a logic circuit 312. Theantenna portion 306 can be a loop antenna which includes a ferrite core,capacitively loaded wire loops, multi-turn coils, etc., similar to theantenna portion 205 of the DCE. The power receiver 308 can include apower receiving coil for receiving power from the power transmissioncoil of the power transmitter 202 by electromagnetic coupling. The powerreceiver 308 can provide power to the chip 304 and/or charge a powersource (not shown) such as a battery.

Generally, the logic circuit 312 generates medical data such as anidentification of the RFID chip 304 and/or the medical item to which thechip is affixed, state, location, date, time, and changes in any data orproperties thereof over time, all of which will be referred to asmedical data. It should be noted that the medical data includessituational data which refers to a) the identity of the RFID chip, theidentity reference for an individual, facility plant, property,equipment to which the RFID chip is affixed, and b) the distance betweenan RFID chip and other RFID chips, the distance between the RFID chipand the DCE, the distance between the RFID and client device such assmartphone or mobile reader device, the identity and any identityreferences of the other RFID chips, DCEs and mobile client devices (i.e.smartphones) with which the RFID communicates, and any obtained from asensor associated with i) the RFID chip or ii) another RFID chip, orclient device (i.e. smartphone) with which the RFID communicates.Examples of the sensor data might be location in three dimensions,acceleration or velocity, displacement relative to some reference,temperature, pressure, etc.

The medical data can also include data indicative of an event such as,for example, near field communication (NFC) established with the DCE oranother RFID chip, a time duration for which the RFID chip 304 has beenwithin a certain location, historical data, etc. Although not shown, thelogic circuit 312 can include or be coupled to a non-volatile memory orother memory source.

The interface 310 can format a received signal into an appropriateformat for processing by the logic circuit 312 or can format the medicaldata received from the logic circuit 312 into an appropriate format fortransmission. For example, the interface 310 can demodulate ASK signalsor modulate data from the logic circuit 310 into ASK signals.

Referring to FIG. 3B, circuit-level portions of the active-type RFIDchip 322 on a medical item 320 will be discussed. The RFID chip 322 caninclude a power source 323, an antenna portion 324, an interface 326, abus 328, a controller 330, a memory portion 332 and a sensing group 334.The power source 323 can be, for example, a battery. Although not shown,the chip 322 can also include a power management portion coupled to thepower source 323.

The antenna portion 324 and interface 326 can be similar to those of thepassive-type RFID chip 304. However, it should be noted that the antennaportion 324 can receive data from other passive-type and active-typeRFID chips as well as the DCE and can send this and other data to theDCE, or other RFID chips.

The sensing group 334 includes sensing portions for sensing contact,motion characteristics such as an acceleration value, whether the chipis within a predetermined distance from another RFID chip, etc, adistance from one or more other RFID chips and/or the DCE, and/ordistance and angle from a base orientation. The sensing group 334 caninclude a temperature sensor, a set of accelerometers for determiningthe acceleration value of the item 320, a plurality of barometers toestimate the vertical position or to recognize vertical movements, adigital compass that collects orientation information about the item 322which may be implemented by any number of methodologies including indoorpositioning using WiFi signals based on utilizing the received signalstrength (RSS) and the fingerprinting method, the Pedestrian DeadReckoning (PDR) approach, Ultrasonic, Pseudolites, NFC, Ultra Wide Band(UWB), microphone and light sensor, an afocal optical flow sensor,camera images and range data captured by a 2D laser scanner, infraredimages used to localize and track moving targets, among otherapproaches, a gyroscope for measuring angular rotation associated withthe apparatus to provide an orientation value, a proximity sensor fordetecting if the chip 322 is within a predetermined distance of anotherchip 322, a touch sensor layer and/or pressure sensor for sensingcontact and magnitude of the pressure, and a geomagnetic sensor forsensing geomagnetic field strength. Preferably, the sensed motioncharacteristics include data represented in the time domain. Theaccelerometers can detect subtle movements along the three axialdirections. The accelerometer reading, when combined with the data fromthe digital compass, barometer, and/or the gyroscope, can facilitatemotion detection. The sensing group 334 can include a separateOpenBeacon active tag or a Sense-a-Tag as described in “ProximityDetection with RFID: A Step Toward the Internet of Things” by Bolić etal., Pervasive Computing, IEEE, (Volume 14, Issue 2), published onApril-June 2015, the contents of which are incorporated herein byreference. Further, in conjunction with or separately from the proximitysensor, the sensing group can include a distance sensor for measuring adistance to a target node such as another RFID chip. The distance sensormay be a received signal strength (RSS) indicator type sensor formeasuring the RSS of a signal received from a target node such as theDCE or another RFID chip. The distance from the target node can beobtained by a plurality of RSS measurements.

The controller 330 is configured according to instructions in the memory332 to generate messages to be sent to the DCE or another chip.Particularly, the controller 330 can be configured to send aregistration message which includes identification data associated withthe RFID chip 322 and thus the medical item 320. Further, in a case inwhich the RFID chip 322 wirelessly provides power to anotherpassive-type RFID chip, the controller 330 can be configured to generatea message including identification data associated with the passive-typeRFID chip, in combination with, or separately from its ownidentification data to the DCE.

The controller 330 can be configured to generate messages includingmedical data indicative of an event. These types of messages can be sentupon receiving a request from the DCE or another entity, upon occurrenceof the event, or at regular intervals. Example events include near fieldcommunication established with another RFID chip, contact detected bythe sensing group 334, positional information, a time duration of suchcontact and position, etc. Specific examples of events will be discussedlater.

It should be noted that the passive-type RFID chip can also include asensing group or be coupled to the sensing group. For example, the RFIDchip 304 can be a Vortex passive RFID sensor tag which includes aLPS331AP pressure sensor. For example, the RFID chip 304 can be a MONZAX-8K DURA or X-2K DURA tag made by IMPINJ™ which include embeddedsensors. Both active and passive types of sensors can include RSSmeasurement indicators. The controller or control logic can determinethe distance from the RSS measurements based upon localizationalgorithms such as, for example, Centroid Location (CL), Weighted CL, orthe Relative Span Exponentially Weighted Localization (REWL) algorithmas discussed in “Experimental Assessment of a RSS-based LocalizationAlgorithm in Indoor Environment” by Pivato et al., IEEE Instrumentationand Measurement Technology Conference, published on May 2010, thecontents of which are incorporated herein by reference.

The RFID chip 302, 320 may be high-frequency (HF) tags,ultrahigh-frequency (UHF) tags, high temperature resistant, autoclaveresistant, ultra low temperature resistant, repeated temperature cyclebetween hot and cold resistant, acid resistant, chemical resistant,abrasion resistant, gamma resistant, water resistant, types among otherspecial application RFID chip types.

Referring to FIG. 11, the server device 1110 includes a transceiver1102, a controller 1104, a first memory portion 1106, and one or moredatabases depicted generally by 1108. The databases 1108 can include amedical item database, a patient database, and a medical professionaldatabase, a location database. That database can be, for example, anatomic data store, a file system, an object database, a documentoriented database, a distributed database, a block chain, anon-relational data store or NoSQL database, a relational databasemanagement system or SQL database, a key-value store, a wide-columnstore, a combination thereof, or other database type. The transceiver1102 receives medical data via the network from the DCE and resourcerequests such as, for example, http requests, via the network, from aclient device. The resource request can include verification credentialssuch as a token issued from a certification authority and a user nameand an information request for an information reply including usageparameters associated with one or more RFID chips. The transceiver 1102sends the information reply including the usage parameters associatedwith the one or more RFID chips to the client device. The transceiver1102 can be similar to the transceiver of the DCE.

The memory 1106 can be one or a combination of a variety of types ofmemory such as RAM, ROM, flash memory, DRAM or the like. Alternatively,the database 1108 can be included in the memory 1106. The memory 1106includes instructions for configuring the controller 1104.

Among the databases 1108, the medical item database stores a pluralityof medical item identifications and usage attributes associated witheach of the item identifications or to which usage attributes associatedwith each of the item identifications stored elsewhere may bereferenced. The usage attributes can include an identification of amedical professional that used the medical item, an identification of apatient for whom the medical item was used, a time duration for whichthe medical item was in a certain location, a series of RFID derivedmessages that include a date and time stamp or unique identifiersreferencing said messages stored elsewhere, etc. The patient databasecan store patient identifications, attributes associated with eachpatient identification such as dispositions, scheduled surgeries,location history, consumed medical items, or references to said datastored elsewhere in a separate schema or separate information system alltogether, etc. The medical professional database can store medicalprofessional identifications, attributes associated with each medicalprofessional such as scheduled surgeries, location history, consumedmedical items, etc. or a reference to said data stored elsewhere in aseparate schema or a separate information system all together.

The controller 1104 is configured according to the instructions in thememory 1106 to determine data in the database 1108 that is associatedwith the identification for each of the one or more RFID chips in theinformation request; generate the information reply including the usageparameters and or a plurality of RFID derived messages previouslycollected and stored and data therein, associated with the one or moreRFID chips based upon the determined data; and store data in the messagefrom the DCE in the medical item database to be associated with theidentification of the first RFID chip.

The controller 1104 is further configured to determine based uponmedical data and events included in messages received from the DCE,whether particular events of interest are likely to have occurred suchas, whether a medical consumable item has been consumed or not, andstore data related to the consumption of the medical consumable item inthe database 1108. The controller 1104 is further configured todetermine based upon the medical data and events, and attributes in thedatabase 1108, whether a never event has or is about to occur, andgenerate a message to be sent in accordance with such determination. Asdiscussed in the second embodiment, the controller 1104 can beconfigured to predict values based upon a trained model such as a neuralnetwork model using machine learning to make these determinations.

The controller 1104 and database 1108 can be configured to performcommand query responsibility segregation in which commands are separatedfrom queries to allow scaling of servers that respond to queriesseparately from servers delegated to responding to messages. Thecontroller 1104 and database 1108 can further be configured to use eventsourcing and/or event streaming to ensure all changes to an applicationstate get stored as a series of events which can be not only queried butreconstructed.

First Embodiment

Referring to FIGS. 4A-4B, a first embodiment will be discussed byexemplary cases in which the DCE 102 receives medical data from one ormore RFID chips. In the case shown in FIG. 4A, the DCE 102 is disposedon a trash receptacle 402. A medical consumable item 404 including afirst RFID chip 406 (passive or active) is placed in the trashreceptacle 402. The DCE 102 establishes communication with the RFID chip406. Particularly, the DCE 102 can periodically generate a broadcastmessage, and receive a registration message and medical data from theRFID chip 406 indicative of a medical event in reply to the broadcastmessage. Alternatively, the RFID chips can self-initiate sending of theregistration message periodically or in response to another externaltrigger

If the RFID chip 406 is passive type, it can send the medical data whilereceiving power from the DCE 102. The registration message can includeidentification information associated with the RFID chip 406. In thiscase, the medical event would be use of the medical consumable item 404(indicated by being in the trash receptacle 402). The DCE 102 can send amessage indicative of the first medical event to be sent by thetransceiver to the server device 114 via a connection to the network112.

In the case shown in FIG. 4B, the DCE 102 is disposed not in the trashreceptacle 402, but in a position such as the ceiling beneficial forestablishing wireless communication coverage for a room. The DCE 102receives medical data from the first RFID chip 406 affixed to themedical consumable item 404, a second RFID chip 408 (passive oractive-type) affixed to the trash receptacle 402, and a third RFID chip412 (passive or active-type) affixed to a patient identification 410such as a wristband. The DCE 102 establishes communication with each ofthe RFID chips 406, 408, 412 by, for example, generating a generalbroadcast message, and receiving registration messages in reply to thebroadcast message, and medical data from the RFID chips indicative ofmedical events. Particularly, the RFID chip 412 sends a messageincluding medical data indicative of a first medical event, which wouldbe the RFID chip 406 of the medical consumable item 404 being withinpredetermined distance from the RFID chip 412 associated with thepatient identification 410. As noted above, the RFID chip (active-typeor passive-type) can include a sensor for detecting near presence ofanother RFID chip. The RFID chip 408 sends a message including medicaldata indicative of a second medical event, which would be the medicalconsumable item 404 being within predetermined distance from the RFIDchip 408 associated with the trash receptacle 402 for more than apredetermined time duration. The RFID chip 406 sends a message includingmedical data indicative of the chip identification. The DCE 102 can sendone or more messages indicative of the medical events to be sent to theserver device 114 via the network connection.

Referring to FIG. 5, exemplary modification to the first embodiment willbe discussed by an exemplary operating environment in which a smartphone502 communicates with the RFID chips. The smartphone 502 generates abroadcast message, and receives messages indicative of medical eventsfrom the RFID chips 514, 516, 518 associated with medical items 506,504, 508. The messages include registrations messages and medical dataindicative of a first, second and third medical events in reply to thebroadcast message. The smartphone 502 can then send this data to the DCE102 directly or via the network 112 or even directly to the server 114.For example, in a large facility such as a hospital, there may be areasin which there is no or very poor wireless coverage from the DCE 102. Inthese cases, a mobile device such as the smartphone 502 can be used toobtain medical data from chips in such areas and transmit the medicaldata to the DCE 102. Similar to the discussion of FIGS. 4A-4B, theevents can be the RFID chips being within a predetermined distance ofeach other.

The smartphone 502 and/or the DCE 102 can be configured to locallypersist and send the medical data to the server 114 either immediatelyupon collecting data or at a subsequent time after a batch of one ormore pieces of data has been collected. The smartphone 502 and/or DCE102 can purge the data sent from volatile or persistent memoryimmediately after successfully sending it or at a later time, eitherautomatically or when prompted.

FIGS. 6-8 are flow diagrams illustrating exemplary operations of the DCEand RFID chips associated with medical items, medical professionals anda patient according to the first embodiment.

Referring to FIG. 6, the operations of the RFID chip and the DCE in asimple scenario will be discussed. At 602 a passive-type RFID chipreceives electrical power wirelessly from the DCE. The wireless powercan be sent along with a regular general broadcast message from the DCEor an interrogation request. Of course if the RFID chip is active-type,this step can be omitted. At 604, the RFID chip sends registrationinformation to the DCE, which records it in its memory. Particularly,the registration information can include the identification of the RFIDchip and the date and time of the registration. At 606, if the RFID chipand/or the DCE determines that an event has occurred, at 608 the RFIDchip sends use parameters associated with the event to the DCE. The DCErecords the usage parameters in its own memory or immediately transmitsthe information to the server to be stored in the medical item database.The event can be, for example, detecting that the RFID chip is withinpredetermined distance from another RFID chip associated with, forexample, the trash receptacle for more than a predetermined timeduration as discussed in FIGS. 4A-4B.

Referring to FIG. 7, the operations of the RFID chip and the DCE in amore complex scenario in which a medical professional such as a doctormeets with a patient will be discussed. At 702, the doctor wearing anidentification such as a badge including an RFID chip (active orpassive-type) enters a room within the communication area of the DCE andthe RFID chip registers with the DCE. A patient with a patientidentification including another RFID chip which has already registeredwith the DCE is already in the room. At 704, the DCE records a firstmedical event indicative of the patient and the doctor being in the sameroom and the start time. At 706, the DCE generates a messagerepresentative of this first medical event to be transmitted to theserver. At 708, the doctor wearing the identification including the RFIDchip leaves the room, and disconnects from the DCE. At 710, the DCErecords the time the RFID chips disconnects as the end time of the firstmedical event, and generates a message representative of the end time ofthe first medical event to be transmitted to the server.

Referring to FIG. 8, the operations of the RFID chip and the DCE in thescenario shown in FIG. 4A will be discussed. At 802, the RFID chipassociated with the medical consumable item connects with the DCE in thetrash receptacle. At 804, the DCE records a medical event indicative ofthe medical consumable item being in the trash receptacle. At 806, theDCE generates a message representative of this medical event to betransmitted to the server.

Referring to the flow diagram of FIG. 10 and the diagrams of FIGS.9A-9G, operation of the DCE 102 and the server according to the firstembodiment will be discussed. In FIG. 9A, the DCE 102 establishes awireless communication coverage area depicted generally by room 900. Apackage 10 including a medical consumable item 20 is in the room 900. Afirst RFID chip 902 is disposed on the package 10 and a second RFID chip904 is disposed on the medical consumable item 20 in the package.

At 1002, the medical consumable item 20 is removed from the package 10as shown in FIG. 9B. At 1004, one or both of the RFID chips 902, 904detects the separation and sends a message to the DCE 102 including amedical event indicative of the separation of the item 20 from thepackage 10.

At 1006, the packaging 10 is placed in a trash receptacle 30 including athird RFID chip 906 as shown in FIG. 9C. At 1008, the third RFID chip906 detects that the packaging 10 is in the receptacle 30 and sends amessage to the DCE 102 including a medical event indicative of thepackaging 10 being in the receptacle 30.

At 1010, a doctor 40 or other medical professional wearing a doctoridentification or badge including a fourth RFID chip 908 has entered theroom 900 as shown in FIG. 9D. The DCE 102 receives a registrationmessage from the fourth RFID chip 908 when it enters the room. Thedoctor 40 holds the medical consumable item 20. At 1012, one or both ofthe RFID chips 904, 908 detects that the item 20 is less than apredetermined distance from the identification card 50, and sends amessage to the DCE 102 including a medical event indicative of the item20 being used by the doctor 50.

At 1014, a patient 60 wearing a patient identification or badge 70including a fifth RFID chip 910 is in the room 900 as shown in FIG. 9E.The DCE 102 can receive a registration message from the fifth RFID chip910 when it enters the room 900. The doctor, for example, holds themedical consumable item 20 near the patient 60. At 1016, one or both ofthe RFID chips 904, 910 detects that the item 20 is less than apredetermined distance from the patient identification card 70, andsends a message to the DCE 102 including a medical event indicative ofthe item 20 being used for the patient 60.

At 1018, when the medical professional 40 is more than a predetermineddistance from the item 20 (or not within a periphery of near fielddetection), at 1020 one or both of the RFID chips 904, 908 detects thatthe item 20 is less than a predetermined distance from the medicalprofessional identification card 50, and sends a message to the DCE 102including a medical event indicative of the item 20 no longer being usedby the medical professional 40 and the time duration for which the itemwas used.

At 1022, when the patient 60 is more than a predetermined distance fromthe item 20 (or not within a periphery of near field detection), at 1024one or both of the RFID chips 904, 910 detects that the item 20 is lessthan a predetermined distance from the patient identification card 70,and sends a message to the DCE 102 including a medical event indicativeof the item 20 no longer being used for the patient 60 and the timeduration for which the item was used for the patient.

At 1026, the medical consumable item 20 is placed in a trash receptacle30 including the third RFID chip 906 as shown in FIG. 9F. At this time,one or both of the RFID chips 904, 906 detects that the item 20 is inthe receptacle 30 and sends a message to the DCE 102 including a medicalevent indicative of the item 20 being in the receptacle 30.

Referring to FIG. 9G, an exemplary conceptual message 920 generated bythe DCE 120 (shown in human readable format) to be sent to the server isshown. The message 920 includes the series of events related to themedical consumable items discussed above. The time data can bedetermined by when the message from the RFID chip was received by theDCE or when it was sent to the server, or may be included in the messagefrom the RFID chip. The location data can be generally the location ofthe DCE 120 and/or the RFID chip. The server device 1110 can store thedata included in the message 920 in the database 1108 in the formatdepicted by 940. Particularly, information parameters can be storedaccording to an identification reference mapped to a given medicalconsumable item identity and/or any other entity identity referenced ina given message containing medical and/or situational data. Examples ofsuch entity identity references include the actual product type orunique product identity associated with a given RFID chip identity, anymedical professional (RFID chip identity associated with a medicalprofessional) that may have been registered in proximity to an RFID chipwith an identity that references a given item, any patient (RFID chipidentity associated with a patient) that may have been registered inproximity to an RFID chip with an identity that references a given item,a room or trash receptacle referenced by a given DCE identity or RFIDchip identity, etc.

The RFID chips can detect separation from another RFID chip or beingwithin a predetermined distance from another RFID chip by the sensorgroup. Alternatively, the detection can be performed by ambient radiofrequency communication techniques which can detect proximity up to, forexample, 70 cm by backscattering. Further, the detection can beperformed at the DCE end by, for example, measuring the RSS of the RFsignal received from the chips.

The server device 1110 can determine what is represented by collectivetransactions based upon the medical data received from the DCE as wellas previously stored medical data in the database 1108. For example, ina case the server device 1110 can determine that a series of eventsrepresent the following:

“Nurse Martin opened external ventricular drain sku #34567 on May 6,2015 at 14:05 and the external ventricular drain packaging was placed intrash receptacle #56789 on May 6, 2015 at 14:05 in operating room number1 at general hospital in Seattle, Wash.”

“Nurse Martin gave external ventricular drain sku #34567 to Dr. Jones atMay 6, 2015 at 14:06 in operating room number 1 at general hospital inSeattle, Wash.”

“Dr. Jones inserted external ventricular drain into patient Ernie Smithon May 6, 2015 at 14:09 in operating room number 1 at general hospitalin Seattle, Wash.”

“Patient Ernie Smith left operating room number 1 at general hospital inSeattle, Wash. on May 6, 2015 at 14:52 and entered the post anesthesiacare unit at general hospital in Seattle, Wash. on May 6, 2015 at 14:59with external ventricular drain sku #34567”

“Patient Ernie Smith left the post anesthesia care unit at generalhospital in Seattle, Wash. with external ventricular drain sku #34567 onMay 6, 2015 at 15:23”

“Patient Ernie Smith arrived in the neurosurgical icu on ward 4G and wasput in room 412 at general hospital in Seattle, Wash. on May 6, 2015 at15:34 with external ventricular drain sku #34567 accompanied by nurseWashington.”

“External ventricular drain sku #34567 was removed from patient ErnieSmith by Dr. Jones and placed in the trash receptacle in theneurosurgical icu on 4G at general hospital in Seattle, Wash. by nurseWilliams on May 9, 2015 at 09:52.”

The server device 1110 may publish (encrypted or unencrypted) messages,for example to a message queue or bus in response to certain events.External client devices or servers (subscribers) can register orsubscribe to listen to particular messages or queues. When particularmessages representing events of interest are received, the subscribingdevices or servers, for example a particular hospital informationsystem, can subsequently carry out downstream activities in response.For the sake of brevity the process of receiving a message from themessage queue or bus is called herein notification. For example, aninventory system may be notified that an external ventricular drain wasconsumed, the electronic medical records system may be notified each daythat the presence of an external ventricular drain with patient ErnieSmith is detected, the medical billing or hospital billing system may benotified that a consumable was used and that it should be charged topatient Ernie Smith, the providers billing system may be notified thatDr. Jones inserted an external ventricular drain catheter #34567 intopatient Ernie Smith on May 6, 2015 and that he removed the catheter onMay 9, 2015 in order to bill out these services, etc.

Second Embodiment

A second embodiment of the system will be discussed by exemplary casesin which parameters such as a position signature of one or more medicalitems is determined based upon medical data from the RFID chips.

Referring to FIGS. 12A-12B, the medical item is a patient operatingtable 1200 and one or more of the RFID chips discussed above withrespect to FIGS. 3A-3B are affixed to the table 1200. The operatingtable 1200 includes a foot cushion portion 1204 disposed on a footportion frame 1201, a center cushion portion 1202 disposed on a centerportion frame 1203, and a head cushion portion 1206 disposed on a headportion frame 1205. The foot cushion portion 1204 includes RFID chip1208. The center cushion portion 1202 includes RFID chips 1209, 1210.The head cushion portion 1206 includes RFID chip 1211. The centerportion frame 1203 includes RFID chips 1212, 1214. Preferably, at leastone of the RFID chips 1209 and 1212 and the RFID chip 1210 and 1214 nearedge of the center portion frame 1203 and cushion portion 1204 is anactive-type RFID chip which includes or is electrically coupled to oneor more or a network of pressure sensors.

Near field communication (NFC) between, for example, RFID chips 1209 and1208, and between, for example, RFID chips 1210 and 1211 can be used toascertain situational knowledge about the operating table configuration.Namely, whether the head of bed is connected (for example, whether therespective RFID chips are within a predetermined range of distance) tothe center portion of the bed or not. Similarly, the presence or absenceof the foot portion of the operating table can be determined from chips1209 and 1208, for example. Information regarding the relative positionand inter-chip distance between chips 1209 and 1212 and 1210 and 1214,for example, can be used to determine whether the cushion for the centerportion of the operating table is in present and in place. Particularly,one or both of RFID chips 1209 and 1208 send registration data includingthe chip identification to the DCE, and sends a message includingmedical data indicating that it has established NFC with the other chipand the identification of the other chip. Similarly, one or both of RFIDchips 1210 and 1211 send registration data including the chipidentification to the DCE, and sends a message including medical dataindicating that it has established NFC with the other chip and theidentification of the other chip. The DCE sends messages including thismedical data to the server device. The server device can determinewhether the foot and head of bed sections are attached to the centerportion of the operating table and from the identity of the chips andeach chip's known reference to specific portions of the operating table,and which end is the foot of the bed based upon the medical data.Particularly, when both of RFID chips 1209 and 1208 have established NFCwith each other, and both of RFID chips 1210 and 1211 have establishedNFC with each other, the location and relative positions of the headfoot and center portions of the patient operating table 1200 can bedetermined.

Referring to FIGS. 13A-13B, a donut-type headrest 1301 (referred to hereas donut) can be used on the patient operating table for patient headpositioning. First and second RFID chips 1302 and 1304 affixed to thedonut 1301 include pressure sensors and/or communicate with pressuresensors in the donut 1301. For example, imbedded just beneath thesurface of the donut are a plurality of pressure sensors situated in aknown configuration, at a known distance apart and in relation to eachother to permit the measurement of the pressure, pressure gradient, andpressure distribution along the surface of the donut. A patient's headmay be oriented in a large variety of ways on the donut 1301. Anyparticular position will result in a specific pressure distribution,herein called a position signature which can be detected by the RFIDchips 1302 and 1304, and transmitted to the DCE along with a date andtime stamp and other data collection related metadata. For example, asshown in FIG. 13B, the RFID chips 1302 and 1304 can detect the pressuredistribution resulting from the weight of the patient's head and neck astransmitted to the donut at points of contact with the patient's neck,chin, ears, and any portion of the patient's face and scalp that comeinto contact with the donut. This data can be transmitted from the RFIDchips 1302 and 1304 to the DCE along with a date and time and other datacollection related metadata. The DCE or server device can determine thepatient's head position based upon this data utilizing algorithmsdeveloped from machine learning techniques including neural networks,support vector machines, genetic programming/genetic algorithms,Bayesian statistics, decision trees, case based reasoning, informationfuzzy networks, particle swarm optimization, simulated annealing, amongothers, that allow for complex pattern recognition, in some cases,leveraging pre-existing or previously collected “training” data, inaddition to the newly acquired RFID chip data to predict an outcome,namely, in this example, the state or position of the patient's head, aswill be discussed more fully below.

Referring to FIG. 13C, the donut 1301 can be used together with theoperating table 1306. The operating table 1306 includes first and secondRFID chips 1308, 1310 on the cushion portion and RFID chips 1312, 1314on the frame portion. When the donut 1301 is initially placed on theoperating table, it is not known whether the donut 1301 is on the footof the table or the head of the table. In the present embodiment,inter-RFID chip distances d1, d2, d3, d4, d5, d6, d7 and d8 aredetermined. For example, chips 1310, 1314 measure the distances d1, d2to the chip 1302 on the donut 1301. RFID chips 1308, 1312 measure thedistances d3, d4 to the chip 1302 on the donut 1301. Further, chip 1308measures the distance d6 to tag 1304. Chip 1308 (or DCE) previouslystores distances d5, d7. Further, chips 1302, 1304 can measure thedistance d8 or the distance d8 can be previously stored. The distancescan be measured by, for example, measuring an RSS of signals returnedfrom other tags. Alternatively, one or more Sense-a-Tags (STs) can beincluded in the RFID tags or deployed separately. The inter-RFIDdistances are included in medical data sent from the RFID tags to theDCE, and are used to determine the relative positions of the donut 1301and the table 1306, and thus where on the table 1306 the donut 1301 islocated.

Referring to FIG. 14A-14B, the data obtained from RFID chips on theoperating table 1402 and the donut 1301 can be used to determine theposition of the patient on the operating table 1402. FIG. 14B shows thedata obtained from the RFID chips 1410, 1414 on the operating table 1402(the patient's position signature) when the patient is positioned on thetable as shown in FIG. 14A. The distance d1 between RFID chip 1410 andRFID chip 1302 (or RFID chip 1304) is shorter than the distance d2between RFID chip 1414 and RFID chip 1302 (or RFID chip 1302). Thus,this data can be used to determine that the patient head locationrelative to the operating table. For example, if RFID chip 1410 isaffixed to the frame or cushion of the head of the bed portion of theoperating table, the information can be used to infer the patient's headis resting on the head portion of the operating table. However, if RFIDchip 1410 is affixed to the frame or cushion of the foot portion of theoperating table, the information can be used to infer that the patient'shead is resting on the foot portion of the operating table, in a reverseorientation (relative to the names of the operating table foot and headportions). Further, RFID chips 1410, 1414 can detect pressuredistribution of the patient's weight on the surface of the operatingtable and communicate this data or position signature along with a dateand time stamp, and other data collection related metadata to the DCE.The pressure data can be used to determine, in this case, that thepatient is on her left side. This pressure distribution data or positionsignature is obtained from pressure sensors within the operating tablecushions or within a pad, for example a gel mat, placed on top of theoperating table across one or more segments of the table. This networkof a plurality of pressure sensors are situated in a known configurationat a known distance apart and in relation to one another and areemployed to collect pressure distribution data which is thencommunicated to an imbedded or non-imbedded RFID chip either via wiredconnection or near field communication. The RFID chip(s) can beinterrogated or can self-initiate communication with the DCE andcommunicate the RFID chip and pressure sensor pad identity along withthe pressure data, location, and time of pressure data collection inaddition to other data collection related meta data. Data can becollected at a variety of time intervals and be used to determine thechange in the patient's position over time. For example, through thevarious phases of an operation, from the time the patient is firsttransferred to the operating, intubated, positioned for the procedure,extubated and transferred off of the operating table. The timestamps andposition signatures obtained at different intervals can be used todetermine, independently or in combination with other data, such as thetype of case scheduled to be taking place in a particular location at aparticular time to give one example, the phase of the operation that thepatient is in at any given time and to predict the probability that theoperation is or is not proceeding as intended, among other things. Forexample, if the patient's position at a particular phase of theoperation is not as expected, such as the patient being positioned proneinstead of supine as scheduled or on the left side instead of the rightside as scheduled, etc. These predictions are made by the DCE or serverutilizing algorithms derived from machine learning techniques discussedmore fully below.

Referring to FIGS. 15A-15B, a skull clamp-type headrest 1500 can be usedto position the patient's head in lieu of the donut discussed above. Thehead rest 1500 can be, for example, a Mayfield headrest, and includes aclamping portion 1501 which includes RFID chip 1504 near the two pinside and RFID chip 1502 near the one pin side of the clamp, an RFID tag1506 near the base adjustment portion, and an RFID tag 1508 in a cornerportion. As shown in FIG. 15A, a swivel portion is joined to theclamping portion 1501. The swivel portion may be similar to the swiveladaptor and base unit described in U.S. Patent Publication No.2006/0190010 to Easton published on Aug. 24, 2006, the contents of whichare incorporated herein by reference. A plurality of RFID chips 1510,1512, 1514, 1516, 1518, 1520, 1522, 1524 can be disposed on thepivot/swivel joints of the swivel portion of the head rest 1500.

The respective orientations of the RFID chips in the headrest 1500 canbe used to determine the exact spatial orientation of the support armand clamping portion. For example, the RFID chip 1506 near theadjustment portion can measure a vector including an orientation angleand displacement of the chips 1502, 1504, 1506, 1508 from a base lineorientation. The vector can be represented as [θ, d1, d2, d3], wherein θrepresents the angle from the baseline orientation, d1 represents thedistance between chips 1506 and 1504, d2 represents a distance betweenchips 1506 and 1508, and d3 represents a distance between chips 1506 and1502. The RFID chip 1504 can measure a distance d4 from chip 1502 (orvice versa). The RFID chip 1506 can send a message to the DCE includingthe vector and the distance d4 (received from one of chips 1502, 1504),the various RFID chip identities, date and time stamp of the datacollection, and other data collection related metadata. The DCE can sendthis message to the server device. The server device can utilize machinelearning techniques described herein to predict or determine theposition of the headrest and thus the position of the patient's headbased upon the vector and d4.

Referring to FIGS. 15C-15F, exemplary operations of the headrest 1500,the DCE and the server will be discussed during two exemplary patientpositions. In these examples, a baseline orientation is determined to beas shown in FIG. 15B. That is, the angle θ of the baseline orientationis 0 degrees. The RFID chip 1506 is an active-type RFID tag, and RFIDchips 1504, 1506 and 1508 are passive-type chips.

In FIG. 15C, a patient's head is shown positioned within the clamp 1501while the patient is in the supine position. Prior to, or at this time,the RFID chip 1506 sends a registration message to the DCE including itsidentification information, data collection date and time stampinformation, and other data collection related metadata. Further,passive-type RFID chips 1504, 1506 and 1508 receive power wirelesslyfrom either the DCE or the RFID chip 1506, and send registrationmessages to the DCE including their identification information,registration date and time stamp information, and other related datacollection metadata.

As shown in FIG. 15D, the RFID chip 1506 detects its displacement angleθ from the baseline orientation. For example, the sensor group of theRFID chip 1506 may include an accelerometer or orientation sensor formeasuring the displacement angle. The RFID chip 1506 also measures thedistances d1, d2, d3 to each of the RFID chips 1504, 1506 and 1508. Thedistance can be obtaining by measuring the RSS of a received signal fromthe chips or by NFC. Further, the RFID chip 1506 receives from one orboth of RFID tags 1502, 1506 the distance d4 between RFID chips 1502 and1504. The RFID chip 1506 send another message including the positionvector [θ, d1, d2, d3] and also the distance value d4 to the DCE. Thevalue of θ is greater than 0 and may be, for example, 30 degrees. Thevalues d2, d3, d4 are greater than their baseline values. The value d1will generally be fixed and can be used for error correction.

In FIG. 15E, a patient's head is shown positioned within the clamp 1501while the patient is in the lateral oblique position. If not registered,the RFID chip 1506 sends a registration message to the DCE including itsidentification information. Then, the RFID chip 1506 obtains theposition vector [θ, d1, d2, d3] and the distance value d4 and transmitsthis data in a message to the DCE as discussed above. The value of θ maybe, for example, 45 degrees. The values d2, d3, d4 are greater thantheir baseline values, but less than the values of the case shown inFIG. 15C. The relative distance between the RFID chips on the head clamp1501, the support arm as shown in 1500, and the RFID chips affixed tothe various portions of the operating table as in the exemplary FIGS.12C and 13C will also be transmitted to allow the determination of thelocation of the head clamp to the operating table (for example, is itaffixed to the head or the foot of the operating table, etc.).

As discussed in embodiment 1, the patient can have a patientidentification such as a wristband which includes an RFID chip thatstores the patient identification. This information will also betransmitted to the DCE as discussed in embodiment 1. Similarly, theidentification of the medical professional will also be transmitted tothe DCE as discussed in embodiment 1. The DCE will send this informationto the server device.

The server device can determine, utilizing machine learning algorithmsas described herein, the patient position based upon the positionsignature received from the RFID chip 1506. For example, when the serverreceives the message including the position vector [θ, d1, d2, d3] andthe distance value d4 shown in FIG. 15C, it can determine that thepatient's head is rotated as shown in FIG. 15C when the values of theposition vector are within a first predetermined range. When the serverreceives the message including the position vector [θ, d1, d2, d3] andthe distance value d4 shown in FIG. 15E, it can determine that thepatient's head is rotated as shown in FIG. 15D when the values of theposition vector are within a second predetermined range different fromthe first range. Moreover, this data can be combined with the medicaldata received from the operating table as shown in FIG. 14B to increasethe accuracy of the determination.

The server device can then compare the patient's position with patientattributes stored in the database to determine if a never event has oris about to occur. For example, if a patient attribute in the databaseindicates that the patient is scheduled to have a surgical procedure ona left portion of his head, yet the server determines that the head ispositioned to expose the right portion as shown in FIG. 15C, the serverdevice determines to a certain probability that a never event has or isabout to occur. Similarly, the server device can compare theidentification of the medical professional with the scheduled surgicalprocedure to confirm if a never event has or is about to occur. Forexample, if a medical professional is scheduled to do a surgicalprocedure on a patient different from the patient identification in themessage received from the DCE, the server device can determine that anever event has or is about to occur. Further, if the server devicedetermines that a medical consumable item such as a sponge with animbedded RFID device is still in the patient as determined from theconsumable's (sponge's) proximity to one or more of the RFID chips, forexample, those affixed to the operating table and or the donut or headclamp at the time of completion of the surgery, the server device maydetermine that a never event has or is about to occur.

Referring to FIGS. 16A-16B, an indwelling catheter such as anendotracheal tube 1600 includes first RFID tag 1602, second RFID tag1604, third RFID tag 1606, and fourth RFID tag 1608 on the air-filledcuff of the tube 1600. At least fourth RFID tag 1608 includes or isassociated with pressure, orientation and temperature sensors. The firstRFID tag 1602, second RFID tag 1604, and third RFID tag 1606 include orare associated with temperature, pressure and orientation sensors. Thepressure sensors are disposed in an orientation where they can enablethe detection and monitoring of the pressure of the cuff of theendotracheal tube at the interface between the cuff and the patient'sairway. The temperature sensors are located along the long axis of theendotracheal tube and have a known position or measured distance fromthe end of the endotracheal tube. As shown in FIG. 16B, the first RFIDtag 1602 and second RFID tag 1604 can preferably be positioned so as tobe exterior and near the patient's mouth, while third RFID tag 1606 andfourth RFID tag 1608 are positioned to be in the patient. The tags cantransmit data to the DCE representative of cuff inflation changes(pressure), the temperature distribution along the endotracheal tube,and the patient's core body temperature over time. The distribution oftemperature along the course of the endotracheal tube at any particularmoment in time used in combination with the known position of eachtemperature sensor within the endotracheal tube is transmitted to theDCE by the associated RFID chip. The DCE or server can then determine,using the machine learning techniques, the likely position of theendotracheal tube leveraging the knowledge of the expected temperaturedrop off along the course of the endotracheal tube as it move from thetrachea to the larynx to the pharynx to where it exits the patient atwhich point it then gets exposed to the ambient temperature in theoperating room. In addition to using this temperature distribution topredict the position of the endotracheal tube in the patient at anygiven moment in time, changes in the temperature distribution along thecourse of the endotracheal tube over time can be used to determinewhether the endotracheal tube has moved in the patient which can beuseful, for example if the system predicts that the endotracheal tube isno longer in ideal position or is potentially at risk of becomingdislodged or conversely if the tube may potentially become positionedtoo deep in the patient's airway. The cuff pressure at any particularpoint in time or changes in the cuff pressure over time can also be usedto predict situations that may pose danger or risk to the patient.

The temperature and pressure distribution can be used to determine ifthe catheter poses a risk to the patient. Particularly, the sensors canmeasure a temperature and pressure at most distal aspect of the catheterand a temperature and pressure gradient along the long axis of thecatheter. The temperature and pressure data can be used to determine (1)when the catheter was introduced (inserted) (2) when the catheter wasdiscontinued (removed) (3) the location of the air-body interface (pointalong the catheter where it exits the surface of the human body) asdetermined from the temperature gradient along the long axis of thecatheter. A trained Neural Network Model (NNM) can be used to predict 1)when a catheter is at risk of falling out based on depth or change indepth over time; and 2) when a catheter may be putting a patient at risk(i.e. catheter days which can be a risk factor for development ofinfection) based on, for example, i) date of placement comparison withcurrent date; and ii) lessons learned (outcomes of clinical interest)from data collected from other patients with similar catheters(supervised learning).

MLA can be used to train the NNM based upon a catheter risk state eventsuch as cases of known catheter discontinuance cases (removal orinadvertent discontinuation) and the temperature or pressure gradientand change thereof over time along the long axis of the catheter foreach case. Thus, machine learning can use the data therein derived fromtemperature or pressure sensors over time and learn on an ongoing basiswhat pattern of change in the temperature gradient denotes risk of oractual discontinuance be it intentional or incidental.

MLA can be used to train the NNM based upon a catheter risk state eventsuch as cases of catheter related infections and event metadata thereof(from hospital information systems—i.e. blood cultures, urine cultures,sputum cultures, white blood cell count, vital signs such as temperaturecurve, coding/claims data, etc.) as well as the temperature data fromcatheter temperature sensors to learn what patterns in the eventmetadata/catheter introduction denote developing risk of a catheterrelated infection.

Referring to FIG. 17, an exemplary case is shown in which the Mayfieldheadrest 1500 can be used in place of the foot frame and foot cushion ofthe operating table (as is typical in neurosurgical procedures) 1202 andthe endotracheal tube 1600 is inserted in the patient. The data from allof the RFID chips can be sent to the DCE, and used to determine theposition of the patient and whether a never event has or is about tooccur. Position data from the RFID chips on the endotracheal tube 1600relative to the position data from the RFID chips on the operating table1202 and the position data from the RFID chips on the Mayfield headclamp 1501 can be used together to improve the prediction of thepatient's head orientation. For example, if RFID chip 1602 is closer inproximity to RFID chip 1502 as compared to its distance from RFID chip1504 (as would be the case in the exemplary case shown in FIG. 17), thisinformation can be used by the system to determine or further confirmthe orientation of the patient's head in the head clamp. Specifically,the combined information from RFID chips on the head rest and thoseimbedded in the endotracheal tube enable more specific determination ofwhere the patient's face or the frontal bone of the skull is relative tothe head clamp as opposed to the patient's occiput or the occipital boneof the skull (back of the head).

Referring to FIG. 18, an eyelid occlusive dressing 1800 includes anembedded RFID tag 1802. Eye protection is used by anesthesiologistsduring neurosurgical cases to prevent eye injury (i.e. cornealabrasions, chemical injury from prep solutions, exposurekeratopathy/keratitis). The eyelid dressing's embedded RFID tag 1802 cantransmit orientation data to the DCE that can be used together with theorientation data from the Mayfield head rest 1500 and the head clamp1501 to determine the orientation of the patient's head by, for example,calculating the proximity of the RFID tag 1802 to those on the Mayfieldhead clamp 1500 and 1501.

Referring to FIG. 19, rather than the donut 1300 shown earlier in FIGS.13A-13B, the head rest can be a horse shoe style headrest 1900 whichincludes RFID tags 1902, 1904 and 1906. Further, the headrest 1900 canbe installed on its own swivel joint. For example, a horse shoe shapedhead rest can be affixed to the Mayfield apparatus rather than the headclamp 1501.

This information along with similar information about the proximity ofthe endotracheal tube 1600 to the RFID chips on the Mayfield head rest1500 enhance the ability of the server and/or DCE to definitivelydetermine the orientation of the patient's head and to predict the sideof the patient's head that will be operated upon, which the system cancross reference with the booking information for the case to determineif all information is in agreement or whether there may be risk for anever event.

It should be noted that in FIG. 1, one server was shown merely for easeof illustration. However, the server 114 may be a plurality of serversand databases connected to the network 112 via a load balancer andperforming X, Y and Z axis scaling of the hardware and software.Particularly, multiple virtual machine instances (VMs) can be runningapplications behind the load balancer on the different servers (X-axis),the servers can perform a functional decomposition to break upapplications into small services (Y-axis), and each server (running theidentical application) can be responsible for a subset of the data(sharing the database) broken up by something that logically makes sensefor the business (i.e. patient last name, type of customer, etc.) with acomponent for routing (Z-axis). Further, although the database 1108 inFIG. 11 is shown as being a portion of the server 1110, it should benoted that the database 1108 can be implemented at one or more separatecomputing devices connected to the server 1110 via the network.

ALTERNATIVE EMBODIMENTS

In alternative embodiments of the system, the medical item can refer tomedical storage units and instruments or items stored in the storageunits similarly to as shown in FIG. 9A. Each of the medical storageunits include RFID tags and/or a DCE and some or all of the instrumentsin the medical storage unit include RFID tags. The RFID tags communicatemessages including medical data to the DCE and therefore the serversimilarly to as shown in FIG. 1. The server can store this informationin the database to determine events or monitor usage patterns of themedical item(s). Further, the server can determine an event based uponinput attributes included in the medical data using a trained model.

Referring to FIG. 20A, the medical item can be an instrument tray case2002 containing various medical instruments such as, for example,medical instrument 2102 shown in FIG. 21. The case 2002 includes an RFIDtag 2004. The RFID tag 2004 may be an autoclavable RFID tag which canwithstand the extreme temperature swings (cold or heat) and pressure ofan autoclave machine (such as shown in FIG. 27). Exemplary autoclavableRFID tags include the DASH XSS, DOT XSS, Pico Plus and Roswell made byXerafy®.

As shown in FIG. 20B, the instrument tray case 2002 may be a sealed wrapcase. The medical instruments 2102 in tray case 2002 may each alsoinclude an RFID tag 2104. The RFID tags 2004, 2104 can sendidentification and medical data to the DCE upon interrogation. Themedical data can include usage data such as the instruments inside thecase 2002, expiration date of any medications, a sterilization historyand a date and time stamp for the interrogation transaction. Althoughnot shown, the wrap can include its own RFID tag to allow thedetermination of when the wrap's RFID tag is no longer in proximity to(or has changed in proximity to) the instrument tray's RFID tag 2004similarly to the medical item 10 shown in FIG. 9A-9B to determine thatthe instrument tray 2002 is no longer sterile (i.e. has been opened).This is very important in allowing the system to be capable ofdetermining when an instrument tray is contaminated, particularly whenthe tray is of the variety that does not have a cover, but also in thecase where it has a cover which has not been opened (even if cover ison, if wrap has been removed, it is contaminated).

Referring to FIG. 22, the medical item can be a medicine storage cabinet2202 such as a code cart. The cabinet 2202 includes an RFID tag 2204 anda plurality of drawers 2206. Each of the drawers 2206 can includemedical instruments as shown in FIG. 21, medicine package 2302 as shownin FIG. 23 or medicines 2408 as shown in FIG. 24. Each of the medicalinstruments in the drawers 2206 can have their own RFID tags (similarlyto FIG. 21).

As shown in FIG. 23, the medicine package 2302 can include a pluralityof medicines 2304, a label 2306 indicating an expiration date associatedwith the medicines 2304 and an RFID tag 2308. The RFID tag 2308 orsimilar RFID tags on the individual medicines 2410 (similar to 2104 inFIG. 21) can send identification and medical data to a mobile devicereader or the DCE upon interrogation. The medical data can include theexpiration date indicated in the label 2306. Each medical item 2410,including medical items 2304 in the medicine package 2302, mayalternatively have its/their own expiration date(s). Any expirationdate(s) may be stored in memory on the respective RFID chip and/orstored in memory on the server, DCE and/or mobile reader device with anidentifier which references the respective RFID chip's identity which inturn is referenced to the identity of a specific medical item.

Referring to FIG. 24, a drawer 2402 may include its own DCE or readerdepicted by 2404 and an RFID tag 2406 incorporating a sensor such as,for example, an accelerator sensor so that opening of the drawer 2402can be detected. The drawer 2402 can also include a plurality ofmedications 2408 which each include an RFID tag 2410. The DCE 2404 caninterrogate the RFID tags 2406, 2410 to determine which medicines 2408are inside the drawer 2402 and when the drawer 2402 is open. Further,the DCE 2404 can determine the identification of an individual such as(returning to FIG. 9D) a medical professional 40 opening the drawer 2402by interrogating the RFID tag 908 of the medical professional'sidentification 50 and in addition capturing the proximity of the RFIDtag 908 to the DCE 2404 and/or RFID tags 2410.

Referring to FIG. 25, the medical item can be an endoscope storagecabinet 2502 similar to as described in U.S. Pat. No. 8,414,471. Thecabinet 2502 can include a DCE 2504 on a top portion thereof. Aplurality of endoscopes 2504 hang in the cabinet 2506 via retainingportions 2506 and hangers (not shown). Each of the endoscopes 2504 caninclude an RFID tag 2508. Further, each of the retaining portions 2506can include an RFID tag which incorporates a sensor portion to detectwhen the respective endoscope has been removed. The DCE 2504 caninterrogate the RFID tags 2508 on the endoscopes 2504 to determine anumber in the cabinet 2502. Further, the DCE 2504 can interrogate theRFID tag of a medical professional who accesses the cabinet 2502,capturing data including the proximity of the medical professional'sRFID tag 908 and the DCE 2504 and/or any RFID tags 2508, 2504 thereinthe cabinet 502 and changes in the proximity over time, and the numberof endoscopes 2504 before and after the medical professional accessesthe cabinet to determine which medical professional used how many of theendoscopes 2504.

Referring to FIG. 26, the medical item 2602 can be an autoclave machine2602 similar to as described in U.S. Pat. No. 5,535,141 (the contents ofwhich are incorporated herein by reference). The autoclave machine 2602includes an RFID tag 2604 for communicating with a DCE, for example,similar to DCE 102 shown in FIG. 9A. Alternatively, the autoclavemachine 2602 can incorporate its own DCE similar to the endoscopestorage cabinet 2504. When a medical item is sterilized by the autoclavemachine 2602, the DCE can receive a message indicative of the medicalitem sterilized and the time it was sterilized from the RFID tag of themedical item or the machine 2602. For example, the RFID tag 2604 can bean active-type RFID tag and the medical item can have a passive-typeRFID tag similar to the tags 902, 904 discussed in FIG. 9A. The RFID tag2604 can include a sensor such as an accelerator sensor to determinewhen the autoclave machine door has been opened and closed. The RFID tag2604 can activate the passive-type RFID tag of the medical item when themedical item is inserted in the autoclave machine 2602 by sensingclosing of the door. The RFID tag 2604 can then transmit a message tothe DCE 102 indicative of the identification of the medical itemsterilized and the time it was sterilized. The DCE 102 can then transmitthis message to the server device 114. The server device 1110 can storeusage parameters associated with the medical item in the database 1108.Particularly, a user can query when the medical item has beensterilized. The database 1108 may include recommended sterilization timeperiods for each medical item.

When a medical item is sterilized by the autoclave machine 2602, the DCEcan receive a message indicative of the medical item sterilized and thetime it was sterilized from the RFID tag of the medical item or themachine 2602.

Similar to as shown in FIGS. 1 and 11, the RFID tag 2604 associated withthe autoclave machine 2602 can communicate with the server 1110 via theDCE 102. Particularly, the controller 1104 can be configured accordingto instructions in the memory 1106 to interpret a plurality of RFIDreading event derived data obtained from a plurality of interrogationsinitiated by the DCE over a given period of time which the server 1110received and stored in its database 1108. At the time of eachinterrogation/RFID reading event, the DCE can determine the identity ofeach medical item 2102, RFID chip 2104 and/or medical personnel 40 RFIDchip 908 present (in proximity) and interrogated (and that of theautoclave 2604 if applicable) and the proximity between each RFID chipand the DCE or each RFID chip and the autoclave RFID chip 2604; eachRFID reading event includes a date and time stamp in addition to othermedical data. The change in distance between RFID chips 2410, 2104, 2004and the DCE and/or RFID chip 2604 in combination with the date and timestamp derived from a series of RFID reading events can be used todetermine when the medical items were approaching and subsequentlyplaced in the autoclave, the likely identity of the medical personnelthat transported the medical items to the autoclave location, the likelyidentity of the medical personnel that placed the items in theautoclave, how long each specific medical item remained in theautoclave, when each specific medical item subsequently was moving awayfrom the autoclave indicative of removal from the autoclave, the likelyidentity of the medical personnel that removed the medical items fromthe autoclave and the likely identity of the medical personnel thattransported the medical items from the autoclave location. In addition,a plurality of temperature sensors associated with the autoclave 2602and/or the RFID chip 2604 (or communicated with by the RFID chip 2604)can provide a reading of the internal temperature at the time of areading event. This data in combination with the medical item2102—autoclave DCE and/or autoclave RFID 2604 proximity data and timestamps and data from readings of the RFID associated with anaccelerometer sensor (described below) can be used to determine how longeach medical item was exposed to what temperature(s).

Referring to FIG. 27, the medical item can be a refrigerated storagecabinet 2702 similar to as described in U.S. Patent Publication No.2011/0202170 (the contents of which are incorporated herein byreference). Particularly, the cabinet 2702 can store medical productsincluding medications, tissues, and blood products such as whole blood,plasma, or platelets, for example, which have a limited shelf life andstringent quality control requirements to maintain the quality of theproducts.

The cabinet 2702 can include its own DCE (depicted by 2704) oralternatively the DCE can be separate similarly to the DCE shown in FIG.9A. The cabinet 2702 includes an RFID tag 2708 incorporating a pluralityof temperature sensors or alternatively communicates with temperaturesensors for detecting the internal temperature of the cabinet 2702.

The cabinet 2702 includes a door 2706 with a sensor for detecting whenopened. The DCE 2704 can interrogate the RFID tag of identification ofthe individual who opened the door and send a message indicative of thismedical data to the server device. For example, the door 2706 can beconfigured to hinder access unless individuals with certain privileges(indicated by their RFID tags) are near the RFID tag 2708 (orsufficiently close to be interrogated by the DC 2704). The cabinet 2702includes a plurality of storage locations 2710 for storing the medicalproducts. Access to the storage locations 2710 can also be configured tobe hindered unless individuals with certain privileges (indicated bytheir RFID tags and/or in combination with a database look up using theunique identifier of their ID badge RFID tag) are near the RFID tag2708. The DCE 2704 can also be configured and deployed to periodically(every X time interval) interrogate RFID tags in proximity. Data fromeach DCE interrogation event may be sent by the DCE to the server 1110immediately or in a batch along with data from other DCE interrogationevents at a time after the any specific interrogation event). This datais stored by the server 1110 in the database 1108. Data from a pluralityof RFID reading events (interrogations), potentially in combination withdata read from the associated cabinet 2702 door 2706 RFID accelerometersensor, collected over time can be used to determine/predict “netevents” that have occurred. For example, the data, including readingevent date and time stamps, from a plurality of DCE/RFID tag readingevents may predict that medical personnel 40 with a specific identityderived from the individuals ID badge's 50 RFID tag's 908 uniqueidentifier approached the cabinet 2702, DCE 2704, RFID tag 2708, openedthe cabinet door 2706, removed a plurality of medical items, for example2304, 2408, closed cabinet door 2706, moved away from cabinet 2702, DCE2704, RFID tag 2708 along with medical items 2304, 2408 which remainedin proximity to the individual 40 (the individuals ID badge 50 RFID tag908) while concurrently moving away from the cabinet 2702. The predicted“net event” (medical personnel 50 of a specific identity 908 removed aspecific medical item 2304, 2408 from cabinet 2702) is determined by theserver using machine learning via its trained neural network models fromprocessing of the plurality of data from the RFID tag reading events andtheir respective date and time stamps. Further, the RFID tag 2708monitors the interior temperature and sends a message representative ofthe interior temperature at specific date and time stamps to the DCE,which forwards this message to the server 1110.

The server 1110 can receive the medical data from the RFIDs of themedical items shown in FIGS. 20A-27. The server 1110 can store themedical data in the database 1108 associated with each medical item orthe medical items stored within the medical item. For example, theserver 1110 can store an identification for the instrument tray case2002 and medical data indicative of what instruments are in the case2002. Accordingly, a user can query the RFID 2004 of the case 2002 andretrieve this information from, for example, the server 114. Forexample, the server 114 can store an identification for the cart 2002,each drawer 2206 of the cart and medical data indicative of what medicalitems are in the drawers 2206. Accordingly, a user can query the RFID2204 of the cart 2202 and retrieve this information from, for example,the server 1110. A similar approach can be used for the endoscope case2502. Further, when a medical professional accesses one of these medicalitems or the items therein, the DCE can interrogate the RFID tagassociated with the identification of the medical professional so thatan access record can be maintained. Changes over time in the specificmedical item 2408 RFID tag 2410 identities in proximity (present at thetime of a specific interrogation reading) to a cabinet 2402, 2502, 2702or its associated DCE 2404, 2504, 2704 or RFID tag(s) 2406, 2506, 2508,2604, 2708 can be used to maintain an inventory record. Further, theserver 1110 can store in the database 1108 a time at which each medicalitem was sterilized in the autoclave machine 2602 or discrete timeranges in combination with internal autoclave temperature readingsduring that time range denoting a period of autoclaving and arecommended sterilization cycle or minimum sterilization requirements(for example, exposure to a minimum required temperature for a minimumduration of time) for the medical item. Therefore, for example, a usercan query the system using a particular medical item RFID tag identityto confirm that the necessary sterilization has taken place.

Returning to FIG. 27, the sensors associated with the RFID tag 2708 ofthe refrigerated storage cabinet 2702 detect the interior temperature.The DCE 2704 periodically interrogates the tag 2708 and the RFIDs 2410of any other medical items 2408 in proximity to send a messageindicative of the temperature and/or the medical items present, forexample 2304, 2408, within the cabinet 2702 and their proximity to thecabinet DCE 2704 an/or the proximity to the cabinet RFID tag 2708 at thetime of the interrogation, as medical data to the server 1110 along withthe date and time of each interrogation which the server 1110 thenstores in the medical database 1108. The server 114 can store in themedical database 1108 associated with the identification for the cabinet2702 a recommended temperature range (minimum and or maximum requiredtemperature) for each of the medical items stored in the cabinet 2702.Therefore, the server 1110 can notify a medical professional when thecabinet 2702 needs to be maintained or when the medical items in thecabinet cannot be used.

In the examples shown in FIGS. 20A-27, another RFID tag storing a uniquelocation information can be affixed to a room. The server can receivethis location identification from this RFID tag directly or via a DCE orreader. The server can store a location database in which medical itemsat locations are entered. Further, the RFID tags can include GlobalPosition System (GPS) capability so that the medical data sent to theserver includes location information.

The DCE discussed in these alternative embodiments can also be orinclude a device reader such as a smartphone 502 shown in FIG. 5 orfixed gateway readers such as, for example, the XARRAY, XSPAN andXPORTAL made by IMPINJ™ or fixed and handheld readers such as theSPEEDWAY R420, SPEEDWAY R220, SPEEDWAY R120, ATID AB700 and TSL 1128also made by IMPINJ™. The DCE can include chips such as the INDY serieschip (INDY RS2000, INDY RS1000, INDY RS500, INDY R2000 or INDY R500,etc.) also made by IMPINJ™ and

Returning to FIGS. 9A-9G, the illustrated scenario is also similar tothe process when, for example, the sterilization case shown in FIGS.20A-20B is opened. The server device can predict consumption of themedical item as shown in FIG. 9G based upon a trained NNM as discussedbelow.

Utilizing Machine Learning

As mentioned above, the server device 1110 (or DCE 102) can utilizemachine learning algorithms to predict events related to, for example,the position and state of the medical items and changes thereof overtime. For example, a trained model can be used to predict when themedicine in the cabinet 2702 is at risk of becoming in an unusable statedue to for, example, storage for a particular duration at a temperaturetoo high. For example, the risk that medical item(s) may be spoiled (nolonger suitable for use) can be predicted from the medical itemidentities, temperature data collected over time from cabinet 2702 incombination with the known required storage criteria for said medicalitems (derived by proxy from NNM training set data where medications ofspecific types were determined to be spoiled after a period of storageat a plurality of temperatures) trained model. Similarly the trainedmodels can make predictions of other “net events” using knowledgederived from NNM training data such as removal of a specific medicalitem from a cabinet 2402, 2502, 2702, instrument tray 2002 or othermedical item by a specific medical worker, successful or compliantsterilization of a medical item (autoclaved for a minimum duration oftime above a minimum temperature), medical items that may pose a patientsafety threat if used because they were inappropriately stored (i.e. atwrong temperature), potential use of a medical item by a medical workerwhen said medical item may pose a safety risk to a patient (item isexpired, item has not been appropriately sterilized, or item was storedimproperly, such as at the wrong temperature). In one exemplary case saythe safety for usage of a medicine requiring storage within a specifictemperature range stored in a cabinet, the server device can train theNNM to generate an output value to make this prediction.

Creation of the NNM

In this case, a NNM, which includes an input layer, one or more hiddenlayers and an output layer is initialized. The input layer includes anumber of input neurons in accordance with the plurality of inputattributes, the output layer including a number of output neurons inaccordance with the quantifiable outcome, and each of the one or morehidden layers including a number of hidden layers with a plurality ofhidden neurons and possibly a bias neuron. The controller is configuredto initialize values of a plurality of synaptic weights of the NNM torandom values. In this case, the input attributes can be temperaturevalues, RFID tag identities (i.e. which are proxies for: the identitiesof the medical cabinet, potentially the location at which the data wascollected, medical items in the medical cabinet, etc.), relatedrespective specific identity of medicines (i.e. amoxicillin suspensionwith a specific lot number and a specific numbered vial, package, suchas blister package, label, syringe, or other identifier) that map to theRFID IDs of the medical items in the cabinet which were interrogated,related sensor temperature reading values and time values associatedwith the data derived from each interrogation event of the RFID tagsfrom which the data is derived.

Each of the plurality of hidden neurons includes an activation function,the activation function can be one of: (1) the sigmoid functionƒ(x)=1/(1+e^(−x)); (2) the hyperbolic tangent functionƒ(x)=(e^(2x)−1)/(e^(2x)+1); and (3) a linear function ƒ(x)=x, wherein xis a summation of input neurons biased by the synoptic weights

The NNM is one or more of a feed forward structure Neural Network;ADALINE Neural Network, Adaptive Resonance Theory 1 (ART1),Bidirectional Associative Memory (BAM), Boltzmann Machine,Counterpropagation Neural Network (CPN), Elman Recurrent Neural Network,Hopfield Neural Network, Jordan Recurrent Neural Network, Neuroevolutionof Augmenting Topologies (NEAT), and Radial Basis Function Network.

To train and validate the NNM, a plurality of past patient cabinet riskstate events with known outcomes are needed. For example, a data setassociated with known medication discontinuance (cabinet internaltemperature associated spoilage of medicine) is needed. The data set caninclude temperature values, medication characteristics, etc. and changestherein overtime (i.e. time series data). The data set can be dividedinto a first set of training data and a second set of validation data.

Training of the NNM

To train the NNM, the controller iteratively performs a machine learningalgorithm (MLA) to adjust the values of the synaptic weights until aglobal error of an output of the NNM is below a predetermined acceptableglobal error. Performing of the MLA includes: generating an output valueof the NNM for each past medication risk state event of the trainingdata based upon the input attributes; measuring the global error of theNNM based upon the output values of the NNM and the quantifiableoutcomes of the past event; and adjusting the values of the synapticweights if the measured global error is not less than the predeterminedacceptable global error to thereby obtain a trained NNM. Here, if theglobal error is never reached after number of outcomes, the model can berevised, such as number of hidden layers, neurons, etc.

Validating of the NNM

To validate the NNM, the controller generates an output value of thetrained NNM for each past risk state events of the validation data,wherein each of the output values represents a calculated quantifiableoutcome of the respective event; and determines if the output valuescorrespond to the quantifiable outcome within the predetermined globalerror.

The creation and training of the NNM can be repeated until validationdata results are satisfactory, defined as output data from the NNM beingwithin the acceptable level of global error from the output values inthe validation data set.

Using the Trained NNM

The controller conducts pre-processing of input attributes of the newdata. The input attributes can be, for example, RFID tag identifier,medicine package identifier, and temperature as mentioned above. Thecontroller generates an output value of the trained NNM based upon theinput attributes of the new event. The input attributes will containtemperature measurements and the medicines in the cabinet. The outputvalue can be a prediction of whether the medicine cannot be used asdetermined from prior data collected from the cabinet, including themedications within it and the internal cabinet temperature at the timeof specific reading or interrogation events, and RFID tags of thecabinet. Finally, the server device can use the trained NNM to predictwhether the current data within the context of data previously collectedover time are consistent with particular outcomes (i.e. use of aspecific medicine in cabinet poses a significant risk to patient).

The MLA for updating the synoptic weights is one or more of ADALINEtraining, backpropagation algorithm, competitive learning, geneticalgorithm training, Hopfield learning, Instar and Outstar training, theLevenberg-Marquardt algorithm (LMA), Manhattan Update Rule Propagation,Nelder Mead Training, Particle Swarm (PSO) training, quick propagationalgorithm, resilient propagation (RPROP) algorithm, scaled conjugategradient (SCG), support vector machines, genetic programming, Bayesianstatistics, decision trees, case based reasoning, information fuzzynetworks, clustering, hidden Markov models, particle swarm optimization,simulated annealing.

While only certain features of the invention have been illustrated anddescribed herein, many modifications and changes will occur to those ofordinary skill in the art. The following claims are intended to coverall such modifications and changes.

What is claimed is:
 1. A system comprising: a medical storage unitincluding a first radio-frequency identification (RFID) chip, themedical storage unit storing a plurality of medical items, wherein eachof the plurality of medical items includes a second RFID chip, whereinat least the first RFID chip includes: a controller configured accordingto instructions in memory to generate a message including identificationinformation associated with the respective RFID chip and medical data;and an antenna portion configured to transmit the message; a readerdevice communicating with the at least one of the first RFID chip andthe second RFID chip, wherein the reader device comprises: a transceiverconfigured to receive the message from the at least one of the firstRFID chip and the second RFID chip; a controller operatively coupled tothe transceiver; and one or more memory sources operatively coupled tothe controller, the one or more memory sources including instructionsfor configuring the controller to generate one or more messagesindicative of the identification information and the medical data to besent by the transceiver to a server device via a network connection;wherein the server device comprises: a transceiver configured to receivethe one or more messages from the reader device; a controlleroperatively coupled to the transceiver; and one or more memory sourcesoperatively coupled to the controller, the one or more memory sourcesstoring: a first database including a plurality of states for themedical storage unit and attributes for each of the plurality of states;a trained neural network model (NNM) for generating an output valuebased upon the medical data; and instructions for configuring thecontroller to determine whether the output value corresponds with one ormore of the attributes associated with one or more of the states in thefirst database.
 2. The system of claim 1, wherein the controller of theserver device is further configured to: perform pre-processing on themedical data to generate an input data set; and generate the outputvalue from the trained model based upon the input data set.
 3. Thesystem of claim 1, wherein in the server device: the one or more memorysources further store a plurality of past risk state events, each of theplurality of past risk state events including a plurality of attributesand a quantifiable outcome; and the controller is further configured to:train a neural network model (NNM) to generate the trained NNM, whereinthe training of the NNM includes: performing pre-processing on theplurality of attributes for each of the plurality of past risk stateevents to generate a plurality of input data sets; dividing theplurality of past risk state events into a first set of training dataand a second set of validation data; iteratively performing a machinelearning algorithm (MLA) to update synaptic weights of the NNM basedupon the training data; and validating the NNM based upon the second setof validation data, wherein the MLA for updating the synoptic weights isone or more of ADALINE training, backpropagation algorithm, competitivelearning, genetic algorithm training, Hopfield learning, Instar andOutstar training, the Levenberg-Marquardt algorithm (LMA), ManhattanUpdate Rule Propagation, Nelder Mead Training, Particle Swarm (PSO)training, quick propagation algorithm, resilient propagation (RPROP)algorithm, scaled conjugate gradient (SCG), support vector machines,genetic programming, Bayesian statistics, decision trees, case basedreasoning, information fuzzy networks, clustering, hidden Markov models,particle swarm optimization, simulated annealing.
 4. The system of claim3, wherein: the NNM includes an input layer, output layer, and aplurality of hidden layers with a plurality of hidden neurons; and eachof the plurality of hidden neurons includes an activation function, theactivation function is one of: (1) the sigmoid functionƒ(x)=1/(1+e^(−x)); (2) the hyperbolic tangent functionƒ(x)=(e^(2x)−1)/(e^(2x)+1); and (3) a linear function ƒ(x)=x, wherein xis a summation of input neurons biased by the synoptic weights.
 5. Thesystem of claim 3, wherein the NNM is one or more of a feed forwardstructure Neural Network; ADALINE Neural Network, Adaptive ResonanceTheory 1 (ART1), Bidirectional Associative Memory (BAM), BoltzmannMachine, Counterpropagation Neural Network (CPN), Elman Recurrent NeuralNetwork, Hopfield Neural Network, Jordan Recurrent Neural Network,Neuroevolution of Augmenting Topologies (NEAT), and Radial BasisFunction Network.
 6. The system of claim 1, wherein the plurality ofstates for the medical storage unit include expiration dates for each ofthe medical items.
 7. The system of claim 1, wherein the plurality ofstates for the medical storage unit include cleaning and maintenancecycles for each of the medical items.
 8. A system comprising: a medicalitem including a plurality of radio-frequency identification (RFID)chips, wherein at least a first RFID chip of the plurality of RFID chipsis a passive-type RFID chip with no battery, wherein at least one of thefirst RFID chip and a second RFID chip of the plurality of RFID chipsincludes: a controller configured according to instructions in memory togenerate a message including identification information and medical dataassociated with the respective RFID chip; and an antenna portionconfigured to transmit the message; wherein the first RFID chip includesan antenna for wirelessly receiving power from a power transmissionsubsystem; a device reader communicating with the at least one of thefirst RFID chip and the second RFID chip, wherein the device readercomprises: a transceiver configured to receive the message from the atleast one of the first RFID chip and the second RFID chip; a controlleroperatively coupled to the transceiver; and one or more memory sourcesoperatively coupled to the controller, the one or more memory sourcesincluding instructions for configuring the controller to generate one ormore messages indicative of the identification information and medicaldata to be sent by the transceiver to a server device via a networkconnection, wherein the server device comprises: a transceiverconfigured to receive the one or more messages from the device reader,the first RFID chip or the second RFID chip; a controller operativelycoupled to the transceiver; and one or more memory sources operativelycoupled to the controller, the one or more memory sources storing: afirst database including a plurality of identification of medical itemsand usage parameters for each of the medical items; and instructions forconfiguring the controller to determine data in the medical itemdatabase that is associated with the identification for the at least oneof the first RFID chip and the second RFID chip; and generate aninformation reply including usage parameters associated with the medicalitem based upon the determined data, the usage parameters include anidentification of a medical professional that used the medical item andan identification of a patient for whom the medical item was used. 9.The system of claim 8, wherein the usage parameters include anexpiration date or temperature parameter associated with the medicalitem.
 10. The system of claim 8, wherein the usage parameters include acleaning and maintenance cycle of the medical item.
 11. The system ofclaim 8, wherein the usage parameters include location data of themedical item.
 12. A server device comprising: a transceiver configuredto receive one or more messages from a mobile device or a datacollection engine (DCE), the one or more messages generated from an RFIDchip and including identification information and medical data for amedical item; a controller operatively coupled to the transceiver; andone or more memory sources operatively coupled to the controller, theone or more memory sources storing: a first database including aplurality of identifications of medical items and usage parameters foreach of the medical items; and instructions for configuring thecontroller to determine data in the medical item database that isassociated with the identification information from the RFID chip; andgenerate an information reply including usage parameters associated withthe medical item based upon the determined data.
 13. The server deviceof claim 12, wherein the usage parameters include an identification of amedical professional that used the medical item and an identification ofa patient for whom the medical item was used.
 14. The server device ofclaim 12, wherein the usage parameters include an expiration date of themedical item.
 15. The server device of claim 12, wherein the usageparameters include a cleaning and maintenance cycle of the medical item.16. The server device of claim 12, wherein the usage parameters includelocation data of the medical item.
 17. The server device of claim 12,wherein the usage parameters include a detail of medical instrumentsincluded in the medical item.
 18. The server device of claim 12, whereinthe transceiver receives an information query from a remote device andto send the information reply to the remote device.